NCT03951623

The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients

The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523, a Syk Inhibitor in Adult Patients of Immune Thrombocytopenia: a Randomized, Double Blinded, Placebo Controlled Phase Ib Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. Cross-over treatment will be allowed during the study.

Detailed description

Approximate 51 to 60 patients will be enrolled in dose escalation (3 cohorts, 8-20 subjects each with the ratio of 3:1 vs Placebo) .

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	HMPL-523	HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
DRUG	Placebo	HMPL-523 matching placebo will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-10-30
• Completion: 2022-07-31
• First posted: 2019-05-15
• Last updated: 2024-07-16

Locations

1 site across 1 country: China